Senior Manager, PV Operations

Overview

In this role you drive global pharmacovigilance operations to ensure timely case processing, regulatory reporting, and compliance across clinical and post-marketing portfolios. You act as the primary operational liaison for PV vendors and cross-functional study teams, translating strategy into actionable plans and ensuring robust, scalable, inspection-ready PV systems. You lead safety operations, SOPs, and audits while supporting high-quality data for signal detection and risk management. This position offers impact at scale within a mission-driven gene therapy company.

Responsibilities

• Lead and improve global safety operations processes for case intake, processing, and submissions, aligning with PV regulations and vendor oversight
• Oversee timely and compliant ICSRs processing and regulatory reporting from all sources
• Act as database administrator for Orchard safety database (Veeva Safety)
• Provide operational oversight of safety case management including performance metrics and quality monitoring
• Guide selection, configuration, validation, and lifecycle management of safety systems with IT and Vendor Safety Systems teams
• Develop and maintain SOPs, work instructions, and training for safety operations
• Support inspection readiness and internal audits, Health Authority inspections, and partner audits with remediation planning
• Collaborate with QA to ensure smooth audit programs for PV components and partners
• Partner with safety physicians/scientists and cross-functional teams to produce high-quality data for signal detection and regulatory reporting
• Lead safety data exchange agreements (SDEAs) operational aspects and manage literature surveillance workflows

Key requirements

• Extensive PV operations experience with leadership in global ICSR management and regulatory reporting
• Experience with safety databases (Veeva Safety preferred)
• Strong knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and their operational implementation
• Experience with PV systems configuration, validation, and maintenance
• Proven ability to lead PV vendors/CRO oversight
• Experience with clinical studies, postmarketing safety, risk management plans, and aggregate reports
• Proven track record supporting Health Authority inspections and audits and project management skills

• Self-motivated with initiative and ownership
• Strong cross-functional collaboration and problem-solving skills
• Effective time management and organizational abilities
• Experience with PV databases and systems (Veeva Safety preferred)
• Knowledge of ICH, GVP, FDA, MHRA, EMA regulations
• SOP design, implementation, and maintenance

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